Adverse drug reactions in neonates: could we be documenting more?

Abstract

Neonates are vulnerable to adverse drug reactions but reports of these events are relatively infrequent. Reporting can be increased by adapting a number of standard techniques to the unique features of neonatal care and pathology. However, clinicians and parents will be reluctant to report information about harms in the absence of mechanisms to ensure that reports affect clinical practice. Improved reporting will depend on education and cultural change that are informed by research about pharmacovigilance in neonatal settings. The efficient use of neonatal adverse drug reaction reports will require harmonization of terminology and interoperable databases.

Keywords::

• adverse drug reaction
• neonates
• pharmacovigilance
• spontaneous reporting scheme

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Pediatric patients, above all newborns and infants, are particularly at risk for experiencing drug-related adverse events, because of specific pharmacodynamic and pharmacokinetic issues.

• Drugs are frequently prescribed to newborns, infants and children in an unlicensed and/or off-label way, exposing pediatric patients to an increased risk of experiencing adverse drug reactions (ADRs).

• Neonatal pharmacovigilance can be improved by stimulating spontaneous reports by healthcare professionals, by parents and by active post-marketing surveillance.

• Data collection needs to include information about the benefits of medicines to allow a benefit–risk balance to be conducted.

• The neonatal clinical context has some unique features and optimal ADR reporting requires neonatal-specific research about pharmacovigilance methodologies.

• Harmonization of terminology and interoperability of data collection systems are required for efficient use of neonatal ADR reports.

• Knowledge translation of information arising from ADR reports is needed and will lead to a virtuous cycle of reporting.